COBALT

• Research type

  Research Study

• Full title

  COmBining memantine And cholinesterase inhibitors in Lewy body dementia Treatment trial

• IRAS ID

  1004660

• Contact name

  John-Paul Taylor

• Contact email

  john-paul.taylor@newcastle.ac.uk

• Sponsor organisation

  Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust

• Eudract number

  2021-003232-88

• ISRCTN Number

  ISRCTN79794378

• Research summary

  Dementia with Lewy bodies (DLB) and Parkinson’s disease dementia (PDD) are related complex illnesses with a wide range of distressing symptoms. People with DLB/PDD have worse quality of life, more complex symptoms, higher care costs, and are more sensitive to medications than people with Alzheimer’s disease (AD).
  Acetylcholinesterase Inhibitors (AChEI) are commonly used medicines that can help people with DLB/PDD by improving day to day functioning and thinking abilities. Another drug which might help is Memantine, used to treat moderate to severe confusion in AD. It may help to improve memory, awareness and the ability to perform daily functions; however, it is not clear if adding Memantine to AChEI is beneficial for people with DLB/PDD.
  The aim of this trial is to find out if adding Memantine to AChEI improves overall health and functioning for people with DLB or PDD.
  COBALT comprises two international, double-blind, placebo-controlled, randomised trials to assess the clinical and cost effectiveness of memantine compared to placebo in patients on an AChEI with DLB (COBALT-DLB) and PDD (COBALT-PDD). We plan to recruit a total of 372 patients and their caregivers/informants from 25 sites in the UK and 5 sites in Australia.
  DLB/PDD patients aged ≥50 with a Mini Mental State Examination score of ≥8, on a stable dose of AChEI will be randomised 1:1 to memantine or placebo for 52 weeks. Both trials are identical in procedure and conduct, with the only variation being the disease group.
  Participants and their caregiver/informant will complete assessments at baseline, 26 weeks (primary, secondary and exploratory outcomes) and 52 weeks (secondary and exploratory outcomes). During these visits assessments will be completed by the patient and their caregiver/informant.
  COBALT is funded by the NIHR Health Technology Assessment programme in the UK and the National Health & Medical Research Council in Australia.

• REC name

  East of England - Essex Research Ethics Committee

• REC reference

  22/EE/0075

• Date of REC Opinion

  7 Jul 2022

• REC opinion

  Further Information Favourable Opinion